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Toxicological information

Genetic toxicity: in vivo

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Administrative data

Endpoint:
in vivo mammalian somatic cell study: gene mutation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1984
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
Deviations:
not applicable
GLP compliance:
yes
Type of assay:
micronucleus assay

Test material

Constituent 1
Reference substance name:
25485-88-5
EC Number:
607-733-0
IUPAC Name:
25485-88-5
Constituent 2
Reference substance name:
cyclohexyl salicylate
IUPAC Name:
cyclohexyl salicylate

Test animals

Species:
mouse
Strain:
CF-1
Sex:
male/female
Details on test animals or test system and environmental conditions:
Male mice were individually housed and females were housed 4/cage and given free access to rodent diet and drinking water except for 16 hours prior and 3 hours post dosing of the high-dose group and 4-6 prior to 3 hours post dosing of the other test groups. The animal room had a light photoperiod of 12 hours.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
Peanut Oil
Details on exposure:
8-week-old CFW-1 (Winkelmann) albino mice (7/sex/group) weighing 20-30 g were gavaged with 3000 mg test substance/kg body weight in peanut oil at a dose volume of 10 ml/kg body weight and euthanized at 24, 48, or 72 hours post dosing.
Duration of treatment / exposure:
dose volume of 10 ml/kg body weight and euthanized at 24, 48, or 72 hours post dosing.
Frequency of treatment:
Once
Post exposure period:
24, 48, or 72 hours
Doses / concentrationsopen allclose all
Remarks:
Doses / Concentrations:
300 mg/kg
Basis:
nominal conc.
Remarks:
Doses / Concentrations:
1500 mg/kg
Basis:
nominal conc.
Remarks:
Doses / Concentrations:
3000 mg/kg
Basis:
nominal conc.
No. of animals per sex per dose:
7/sex/group
Positive control(s):
Positive control (20 mg/kg body weight of Endoxan)

Examinations

Tissues and cell types examined:
Bone marrow
Details of tissue and slide preparation:
The smears were fixed in methanol, rinsed with distilled water 2x, stained in 10% Giemsa, rinsed with distilled water, and air-dried. The stained smears were examined by light microscopy to determine the incidence of micronucleated cells per 1000 polychromatic erythrocytes.
Evaluation criteria:
The proportion of polychromatic to normochromatic erythrocytes was assessed by examination of at least 1000 erythrocytes and the number of micronucleated normochromatic erythrocytes was recorded.
Statistics:
Statistical analyses were conducted using the tables of Kastenbaum and Bowman.

Results and discussion

Test results
Sex:
male/female
Genotoxicity:
negative
Toxicity:
no effects
Vehicle controls validity:
valid

Any other information on results incl. tables

Dose: 300 mg/kg-Effects:no effects. Results:No mortalities; no statistically significant change in number of micronucleated polychromatic erythrocytes or micronucleated normochromatic erythrocytes; no statistically significant change in the ratio of polychromatic to normochromatic erythrocytes compared to vehicle control.
Dose: 1500 mg/kg-Effects:no effects. Results:No mortalities; no statistically significant change in number of micronucleated polychromatic erythrocytes or micronucleated normochromatic erythrocytes; no statistically significant change in the ratio of polychromatic to normochromatic erythrocytes compared to vehicle control.
Dose: 3000 mg/kg-Effects:no effects. Results:No mortalities; no statistically significant change in number of micronucleated polychromatic erythrocytes or micronucleated normochromatic erythrocytes at any of the 3 sampling times; no statistically significant change in the ratio of polychromatic to normochromatic erythrocytes compared to vehicle control.

Applicant's summary and conclusion

Conclusions:
Under the conditions of this study, the test substance did not show any evidence of mutagenic potential when administered orally.
Executive summary:
Under the conditions of this study, the test substance did not show any evidence of mutagenic potential when administered orally.